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Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00811330
First received: December 17, 2008
Last updated: December 29, 2008
Last verified: December 2008
History of Changes
  Purpose

The purpose of the study is to see if statin therapy will optimize myocardial response to cardiopulmonary bypass during aortic valve replacement (AVR) for aortic valve stenosis (AVS) (Phase I) and optimize left ventricular reverse remodeling following AVR (Phase II). Preliminary evidence indicates that perioperative statin therapy reduce mortality and morbidity following cardiac surgery. Pleiotropic effects of statins may induce myocardial preconditioning and optimize myocardial and systemic responses to cardiopulmonary bypass during AVR. Furthermore statin therapy after AVR may contribute to an optimal left ventricular reverse remodeling.


Condition Intervention Phase
Aortic Valve Stenosis
Ventricular Hypertrophy
 Drug: Atorvastatin 80 mg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • ♦ Phase I: To study changes on inflammatory markers after aortic valve replacement. ♦ Phase II: To study changes in left ventricular mass at the end of the study (12 months). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase I: To study changes on mitochondrial function, reactive oxygen species, and perioperative systolic and diastolic functions. Phase II: To study changes on clinical status, systolic and diastolic functions during the one-year follow-up. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Atorvastatin 80 mg.
Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
 Drug: Atorvastatin 80 mg
Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
No Intervention: 2: No Atrovastatine

  Eligibility

Ages Eligible for Study:   70 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > or = 70 years and < 80 years
  • Severe aortic valve stenosis
  • Indication for aortic valve replacement by bioprothesis
  • Ejection fraction > or = 50%
  • Without treatment with statin- No renal failure
  • Informed consent signed

Exclusion Criteria:

  • Ischemic heart disaese
  • Concomitant surgery to aortic valve replacement
  • Emergency surgery- Known intolerance for statin
  • Pregnant woman
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811330

Contacts
Contact: Michel KINDO, MD 33.3.69.55.08.11 michel.kindo@chru-strasbourg.fr

Locations
France
Service de Chirurgie Cardio-VasculaireHôpital Civil Recruiting
Strasbourg, France, 67 091
Contact: Michel KINDO, MD     33.3.69.55.08.11     michel.kindo@chru-strasbourg.fr    
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Michel KINDO, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: C. GEILLER, Directeur Adjoint chargé de la Recherche Clinique et des Innovations, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00811330     History of Changes
Other Study ID Numbers: 3963
Study First Received: December 17, 2008
Last Updated: December 29, 2008
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Left ventricular hypertrophy
Aortic valve stenosis
Aortic valve replacement
Cardiopulmonary bypass
 Statins
Myocardial preconditioning
Left ventricular reverse remodeling

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Hypertrophy
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical
Atorvastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013